Evidence map›Paper›PMID 35284994›Full record

ArticleNeurology and therapy2022

COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab.

Anne H Cross, Silvia Delgado, Mario Habek, Maria Davydovskaya, Brian J Ward, Bruce A C Cree, Natalia Totolyan, Ratnakar Pingili, Linda Mancione, Xixi Hu and 6 more

Erratum issuedOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.6field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 26 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 11 institutions in 6 countries.

Anne H CrossDepartment of Neurology, Washington University, St. Louis, MO, USA. crossa@wustl.edu.
Silvia DelgadoUniversity of Miami Miller School of Medicine, Miami, FL, USA.
Mario HabekUniversity Hospital Center Zagreb, University of Zagreb, School of Medicine, Zagreb, Croatia.
Maria DavydovskayaMoscow State Public Healthcare InsCity Clinical Hospital 24, Moscow, Russia.
Brian J WardInfectious Diseases Division, Research Institute of the McGill University Health Centre, Montreal, QC, Canada.
Bruce A C CreeUCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.
Natalia TotolyanFirst Saint Petersburg State Medical University, St. Petersburg, Russia.
Ratnakar PingiliNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Linda MancioneNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Xixi HuNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Roseanne SullivanNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Wendy SuNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Ronald ZielmanNovartis Pharma B.V., Amsterdam, The Netherlands.
Ayan Das GuptaNovartis Healthcare Private Limited, Hyderabad, India.
Xavier MontalbanDepartment of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Kevin WinthropSchool of Public Health at Oregon Health and Science University, Portland, OR, USA.
Novartis (United States) · USCentre d'Esclerosi Múltiple de CatalunyaCity Clinical Hospital · RUMcGill University Health Centre · CANovartis (India) · INNovartis (Netherlands) · NLOregon Health & Science University · USUniversity of California, San Francisco · USUniversity of Miami · USUniversity of Zagreb · HRWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe SARS-CoV-2 pandemic necessitated better understanding of the impact of disease-modifying therapies on COVID-19 outcomes and vaccination. We report characteristics of COVID-19 cases and vaccination status in ofatumumab-treated relapsing multiple sclerosis (RMS) patients.

methodsCOVID-19 data analyzed were from the ongoing, open-label, long-term extension phase 3b ALITHIOS study from December 2019 (pandemic start) and post-marketing cases from August 2020 (ofatumumab first approval) up to 25 September 2021. COVID-19 cases, severity, seriousness, outcomes, vaccination status, and breakthrough infection were evaluated.

resultsAs of 25 September 2021, 245 of 1703 patients (14.4%) enrolled in ALITHIOS receiving ofatumumab (median exposure: 2.45 years) reported COVID-19 (confirmed: 210; suspected: 35). Most COVID-19 was of mild (44.1%) or moderate (46.5%) severity, but 9% had severe/life-threatening COVID-19. There were 24 serious cases (9.8%) with 23 patients hospitalized; 22 recovered and 2 died. At study cut-off, 241 patients (98.4%) had recovered or were recovering or had recovered with sequelae and 2 (0.8%) had not recovered. Ofatumumab was temporarily interrupted in 39 (15.9%) patients. Before COVID-19 onset, IgG levels were within the normal range in all COVID-19-affected patients, while IgM was < 0.4 g/l in 23 (9.4%) patients. No patient had a reinfection. Overall, 559 patients were vaccinated (full, 476; partial, 74; unspecified, 9). Breakthrough infection was reported in 1.5% (7/476) patients, and 11 reported COVID-19 after partial vaccination. As of 25 September 2021, the Novartis Safety Database (~ 4713 patient-treatment years) recorded 90 confirmed COVID-19 cases receiving ofatumumab. Most cases were non-serious (n = 80), and ten were serious (1 medically significant, 9 hospitalized, 0 deaths). Among 36 of 90 cases with outcomes reported, 30 recovered and 6 did not recover.

conclusionCOVID-19 in RMS patients on ofatumumab was primarily of mild/moderate severity and non-serious in these observational data. Most recovered from COVID-19 without treatment interruption. Two people died with COVID-19. Breakthrough COVID-19 despite being fully/partially vaccinated was uncommon.

Indexed as

ALITHIOSAnti-CD20 therapyB-cell therapyCOVID-19OfatumumabPost-marketingRelapsing multiple sclerosisSARS-CoV-2Vaccination

Identifiers

PMID35284994
PMCPMC8918079
OpenAlexW4220742828

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.